Extending Medicare Reimbursement in Clinical Trials (2000) / Chapter Skim
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1Executive Summary BACKGROUND Clinical trials have become an essential component of modern medical care. The breakneck speed of medical advances and the increased effort to base clinical decisions on reliable evidence place clinical trials in an ever more prominent position between medical innovation and medical practice.
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EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS2 "preauthorize" care (as do many commercial insurers) the uncertainty cannot be dispelled in advance.
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EXECUTIVE SUMMARY 3 named only "cancer trials," while others have pointed to "cancer and other lifethreatening diseases." Agreements to pay for treatment in cancer trials have been drawn up between the National Cancer Institute (NCI) and the departments of Defense (DoD)
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EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS4 fected by interventions that were not only ineffective but harmful)
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EXECUTIVE SUMMARY 5 payment for care in clinical trials on a case-by-case basis. In addition, private insurers have been involved in supporting specific trials (e.g., the Blue Cross/Blue Shield Association was instrumental in initiating a trial of high-dose chemotherapy with bone marrow transplant rescue for women with advanced breast cancer)
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EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS6 By the time of the hearing, HCFA had already changed its policy to allow reimbursement for patients in certain trials involving investigational devices (FDA "Category B" devices, which are refinements of, or very similar to, approved devices) but not for trials of other types of interventions.
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EXECUTIVE SUMMARY 7 · interviews with private-sector clinical trial sponsors conducted for this study who stated that, while they do cover the costs of "protocol-induced" services, in general they do not provide money to pay for routine patient care; they expect providers to bill insurers for those costs, · deduction, given the lack of another obvious source of payment for most routine care in trials, and · lack of evidence from any source that HCFA and other insurers are not reimbursing for this care. Providers violated no clear rules in billing for routine patient care costs in clinical trials because no such rules were ever codified.
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EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS8 ventions (except category B devices for which reimbursement is allowed under agreement with FDA, and certain procedures as described in recommendation 2) , of data collection and record keeping that would not be required but for the trial, or of other services to clinical trial participants necessary solely to satisfy data collection needs of the clinical trial ("protocol-induced costs")
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EXECUTIVE SUMMARY 9 recommendation is not intended to influence the criteria or processes HCFA uses to decide on c verage of new procedures under usual medical care. It applies only when a trial of a procedure is being done -- for all the reasons that trials are done -- and claims for reimbursement for the procedure are submitted by practitioners.
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EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS10 recommendation for procedures (No.
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EXECUTIVE SUMMARY 11 Under point-of-service plans, patients should have the right to go outside the managed care network to participate in a trial, under the terms stipulated in the plan for point-of-service care, but no such right should be inferred under plans that limit enrollees to the plan's providers. This recommendation is not comprehensive, but is suggestive of a policy for managed care.
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EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS12 dation follows the model of the ongoing study of lung volume reduction surgery, which grew out of collaboration among HCFA, NIH, and the Agency for Health Care Policy and Research (AHCPR) , at HCFA's initiative.
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EXECUTIVE SUMMARY 13 ADMINISTRATIVE AND COST IMPLICATIONS Implementation of the committee's recommendations would likely cause some increase in administrative costs to HCFA. In making its recommendations, the committee strove to minimize potential administrative burdens.
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EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS14 ment for routine care for patients in clinical trials, the Medicare statute has been widely interpreted to exclude reimbursement for such care. However, evidence is ample to suggest that providers submit claims for routine care for Medicare beneficiaries in trials without noting the existence of the clinical trial, and HCFA's financial contractors usually pay them.
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